MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-23 for TITANIUM VENOUS PORTAL 21-4003 manufactured by Pharmacia Deltec.
[20193177]
At the start of surgery while using flurouscopy, it was noted that the port-a-cath tip (distal portion) was in the right atrium broken loose from the remaining portion of the port-a-cath. The port-a-cath tip was removed the following day by the cardiologistdevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2496 |
| MDR Report Key | 2496 |
| Date Received | 1993-02-23 |
| Date of Report | 1993-02-02 |
| Date of Event | 1993-01-20 |
| Date Facility Aware | 1993-01-20 |
| Report Date | 1993-02-02 |
| Date Reported to FDA | 1993-02-02 |
| Date Reported to Mfgr | 1993-02-01 |
| Date Added to Maude | 1993-03-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TITANIUM VENOUS PORTAL |
| Generic Name | PORT-A-CATH |
| Product Code | LKG |
| Date Received | 1993-02-23 |
| Catalog Number | 21-4003 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 2321 |
| Manufacturer | PHARMACIA DELTEC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-02-23 |